FDA wants prescriptions required for antibiotics given to animals

Wednesday

Apr 11, 2012 at 12:01 AMApr 11, 2012 at 10:17 AM

The Food and Drug Administration called on drug companies Wednesday to help limit the use of antibiotics given to farm animals, a decades-old practice that scientists say has contributed to a surge in dangerous, drug-resistant bacteria.

MATTHEW PERRONE

The Food and Drug Administration called on drug companies Wednesday to help limit the use of antibiotics given to farm animals, a decades-old practice that scientists say has contributed to a surge in dangerous, drug-resistant bacteria.

Antibiotics are mixed with animal feed to help livestock, pigs and chickens put on weight and stay healthy in crowded barns. Scientists have warned that this routine use leads to the growth of antibiotic-resistant germs that can be passed to humans.

The FDA has struggled for decades with how to tackle the problem because the powerful agriculture industry says the drugs are a key part of modern meat production.

Under the new FDA guidelines, the agency recommends antibiotics be used "judiciously," or only when necessary to keep animals healthy. The agency also wants to require a veterinarian to prescribe the drugs. They can currently be purchased over-the-counter by farmers.

"Now you have a veterinarian who will be consulting and providing advice to these producers, and we feel that is an important element to assure that they are in fact using these drugs appropriately," said William Flynn, a deputy director in FDA's veterinary medicine center.

The draft recommendations by the FDA are not binding, and the agency is asking for drug manufacturers' cooperation to put the limits in place. Drug companies would need to adjust the labeling of their antibiotics to remove so-called production uses of the drugs. Production uses include increased weight gain and accelerated growth, which helps farmers save money by reducing feed costs. The FDA hopes drugmakers will phase out language recommending those uses within three years.

But the voluntary approach was met with skepticism by some public health advocates, who said they do not trust the drug industry to voluntarily restrict its own products.

"This is not an issue where trust should be the measure. This is an issue where the measure is whether or not the FDA has fulfilled its authority of protecting public health," said Richard Wood, Chair of the Keep Antibiotics Working coalition, in a statement.

FDA officials said that a formal ban would have required individual hearings for each drug, which could take decades.

"The process we would have to go through is a formal hearing process, product-by-product that is extremely cumbersome," said Mike Taylor, FDA Commissioner for foods. "There's no point in going through those legalistic proceedings when companies are willing to make this shift voluntarily."

Taylor said the FDA has consulted closely with animal drugmakers, and expects them to support the measures.

The debate over antibiotics has long pitted the benefits for producing safe, low-cost meat against the risk of contributing to dangerous antibiotic-resistant bacteria that can infect humans. In its guidelines Wednesday, the FDA said the benefits for meat production do not warrant overuse of the drugs.

"FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use," the agency states.

The rollout from FDA comes at an unusual time in the agency's attempts to curb antibiotic use in animals. Last month a federal court judge ordered the agency to take action on its own 35-year-old rule that would have banned non-medical use of two popular antibiotics, penicillin and tetracycline, in farm animals.

The FDA issued the rule in 1977 but never enforced it, following vigorous pushback from members of Congress and lobbyists for farmers and drugmakers. Four public safety groups sued the agency to act on the regulation, winning the case handed down in the U.S. District Court of Southern New York on March 22. The agency was given 60 days to appeal the decision.

The waning effectiveness of antibiotics has been a global health concern for several decades, attracting the attention of the World Health Organization, the Institute of Medicine and other health groups. As bacteria have grown more resistant, new and more deadly forms of malaria, staph and other infections that were once easily treatable have emerged across the globe.

Experts say overuse of antibiotics in both animals and humans has contributed to the problem. Both medical societies and government agencies have launched educational programs designed to educate physicians on appropriate prescribing of antibiotics.